Scientist/Senior Scientist, Upstream, Process Development & Manufacturing (Biologics)
External
Oruka · RemotePrepare for this interview
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About the role
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. Job Title: Scientist / Senior Scientist, Upstream, Process Development & Manufacturing (Biologics) Location: Hybrid - Waltham, MA required to be in-office 3 days/week -OR- Remote Position Overview: We are seeking an experienced and motivated Scientist/Senior Scientist to support upstream manufacturing activities. This role will be instrumental in contributing to process development and delivery of clinical trial material at CDMOs. The ideal candidate will collaborate cross-functionally within the CMC team including downstream, analytical, and drug product and other stakeholders such as QA, regulatory, and program management. The successful candidate will help support CMC strategy in a fast-paced, innovative environment. You will be an integral part of a growing team with an opportunity to contribute towards developing best-in-class biotherapeutics.
Responsibilities
- Support cell culture process development and manufacturing activities at external CDMOs.
- Execute and support upstream process development, scale-up, and tech transfer to enable drug substance supply.
- Partner closely with CDMOs to execute fit‑for‑purpose upstream processes aligned with development timelines.
- Support planning and execution of drug substance manufacturing campaigns, including batch record review, sampling plans, deviations, investigations, and change management.
- Serve as person‑in‑plant (PIP) during key manufacturing campaigns to support real‑time issue resolution.
- Identify and mitigate technical and development risks using phase‑appropriate strategies.
- Manage upstream timelines and deliverables to ensure on‑time material delivery and effective cross‑functional handoffs.
- Apply phase‑appropriate QbD principles and analyze process data to support development decisions.
- Contribute to upstream sections of regulatory submissions (INDs, IMPDs).
- Travel up to 20-25% to support CDMO activities.
Requirements
- PhD or Master's degree in Engineering or Biological Sciences with ~3-5 years of experience in upstream process development and/or manufacturing of biologics.
- Strong hands‑on expertise in CHO cell culture process development, scale‑up, media optimization, and bioreactor operations; mAb experience preferred.
- Solid understanding of upstream process parameters, product quality attributes, and troubleshooting in clinical manufacturing.
- Experience supporting or leading upstream tech transfer to CDMOs.
- Familiarity with phase‑appropriate cGMP and development regulatory expectations.
- Demonstrated ability to analyze and interpret process and manufacturing data.
- Exposure to upstream process characterization (PC) and process performance qualification (PPQ) is a plus
- Strong written and verbal communication skills and ability to work effectively with cross‑functional and external partners.
- Self‑motivated, execution‑focused, and comfortable operating in a fast‑paced, early‑stage biotech environment.
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